mRNA Analytical Development & Characterization Services

Analyzing mRNA samples can be challenging due to the complexity of the Drug Substance intermediates and the final formulated LNP encapsulated Drug Product. These challenges can be even more daunting when trying to manage multiple CDMOs and CROs depending on their areas of expertise. BA Sciences has rolled out a comprehensive array of mRNA analytical services that provide regulatory-tested methodologies for every aspect of characterizing the purity, potency, and identity of mRNA products in a one-stop shop format. BA Sciences strives to provide mRNA analytical services that are tailored to your manufacturing platform. Phase-appropriate qualification strategies are employed and non-cGMP in-process/scale-up optimization services offerings are available. See how we can help!



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mRNA Analytical Development:

Full cGMP characterization is not always the solution when optimizing In Vitro Transcription and LNP formulation processes.  BA Sciences offers a panel of tests critical to the rapid turnaround time you need in a non-cGMP format. Common assays our clients utilize include:

  • Size, Integrity, and Purity of mRNA constructs via capillary electrophoresis
  • In Vitro Transcription Concentration via Nanodrop
  • Impurity analysis (including dsRNA, pDNA, and residual protein)
  • Polydispersity Index and Particle Size of LNP Formulations
  • Lipid Identity via UPLC

mRNA Raw Material Testing

Accurate characterization of the raw materials utilized in your In Vitro Transcription (IVT) and Lipid Nano Particle (LNP) Drug Product processes is critical to ensure that impurities do not compromise the integrity of your intended formulation.

BA Sciences specializes in cGMP Raw Material Testing using USP methods and custom-validated methods. Whether you require testing support for clinical-phase materials or commercial release, BA Sciences can provide reliable, fit-for-purpose solutions tailored to your needs.

Stability

Cold chain stability studies are paramount for the stability evaluation of mRNA and LNP-encapsulated Drug Products. BA Sciences has extensive -80°C and -20°C stability capacity and specialized critical assay control for cold chain products and freeze-thaw evaluations. In addition to standard stability storage in cGMP-controlled environments, see below for our stability service management areas of expertise.

BA Sciences can help you with:

  • Stability protocol development      
  • Commercial Release Studies
  • Clinical Phase Stability with an emphasis on stability indicating assays
  • Formulation Development & Optimization
  • Stability
  • Freeze Thaw Studies

Why Choose BA Sciences?

Expertise is critical when testing complex and highly sensitive pharmaceutical products, such as mRNA vaccines and related therapies. At BA Sciences, our experienced scientists leverage their specialized knowledge and technical expertise to deliver reliable, high-quality testing results. Our commitment to delivering high-quality services tailored to each client’s unique needs includes providing a dedicated project manager who serves as your primary point of contact throughout the entire process. Every stage of the project is carefully planned and executed with a results-driven approach designed to help ensure products meet the necessary quality, safety, and efficacy requirements before reaching the market.

Companies worldwide trust BA Sciences for mRNA therapeutic analysis supporting cell and gene therapy development. Our expertise and experience enable us to evaluate critical quality attributes and help ensure products meet the quality requirements necessary for successful development. To learn more about how we can support your product development program, connect with us today to discuss your project with one of our experts.

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